Senior Regulatory Affairs Executive/Team Lead/Manager/Project Manager

Job Summary:

Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients’ needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants.

Requirements:

Our office in Maidenhead, Berkshire is the European Hub for all our near-shore project management. We are now looking for new team members who are looking for a fresh challenge. Would you like to assist our BD team and design strategies for new projects? Could you mentor a team of junior staff, whilst meeting client deadlines? How would you fare if asked to juggle multiple projects? Are you brave enough to guide a client through a regulatory process?

This is an exciting opportunity to join our diverse team of Regulatory Professionals. Our organisation is consciously made up of a variety of backgrounds – biologics to OCT, development to maintenance, orphans to generics – knowledge sharing and continuous learning is an important part of everyday life at Genpact Pharmalink. We have our own Regulatory Affairs University which offers our employees the chance to keep their skills fresh, learn new topics and keep up with industry changes. Learn, grow and succeed with us.

You will work directly with some of the largest pharmaceutical companies in the world to drive regulatory projects forward and be accountable for deliverables.

Your duties as a regulatory affairs team representative may include:

•Developing solutions to regulatory or business problems where no clear precedence exists.

•Functioning independently as a decision-maker on regulatory issues; and ensuring that deadlines are met;

•Effectively communicating, preparing, and negotiating both internally and externally with various regulatory agencies.

•Managing the various stages of a project lifecycle: initiation, monitoring, management, escalation, closing.

•Assist in the development of global regulatory strategy and update strategy based upon regulatory changes

•Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

•Working closely with a team of employees and contractors, potentially have line management or mentoring responsibilities.

As a minimum, you should have:

•Proven experience in Regulatory Affairs

•A life sciences BSc or equivalent qualification

•Excellent verbal, written and organizational skills

•Be able to manage multiple priorities and projects and deadlines

•Be team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity working environment. Experience in third party contract operations is preferred.

•Preferred experience working in OTC, Pharma, consumer goods organization, managing cross functional teams, planning short and long term initiatives.

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